Amar Alwitry has a Masters in Medical Law and regularly takes on clinical negligence medico-legal work. He is a Speciality Advisor to the CQC and PSIRF Medical Ambassador to Spire Hospitals. He is also author of "Complaints, Litigation and Clinical Errors" published by Taylor and Francis, a book for all medical and allied professionals.
I recently had the privilege of presenting at the Medicolegal Conference 2024 on the issue of Consent. The talk was interactive and involved questions posed to the audience regarding consent conundrums. Bearing in mind I had a very select audience of learned experts I expected there to be general consensus in the responses to my questions. However, I was amazed to see a lot of variance in the answers with often a 50:50 split in viewpoints. It occurred to me if we were “experts” and we disagreed and had a big variance of opinion how can we properly fulfil our role to the Court to assist in the maintenance of justice?
Prompted by the talk I am writing this article to introduce a new series of opinion variance surveys presenting to the readership questions regarding their thoughts on some ethical dilemmas related to medical law.
Below are this edition’s questions, which I would be grateful if you could answer by scanning the QR code.
1- An ophthalmologist is planning cataract surgery for a patient. As part of the consent process, he explains to the patient the risk of infection. He explains to the patient that there is a risk of infection, but he has never had one in his entire career. The pre-printed consent form states a risk of 1:1000 of endophthalmitis
(intraocular infection).
The patient subsequently develops an infection and loses their vision in that eye.
The patient subsequently litigated over the issue of consent. It is alleged that the surgeon gave the patient inappropriate assurance regarding the risk of endophthalmitis.
Defence argument: “It is important that patients are given accurate information about the risks of surgery. It is therefore entirely appropriate for the surgeon to present to his patients his audited complication rates. Usually, general complication rates are a reasonable starting point however the surgeon owes a duty to his patient to reflect true real world complication rates in his hands. He was the only one who was going to perform the operation and therefore the consent process was acceptable.”
Claimant argument: “It was entirely inappropriate to use personalised complication rates for the consent process. Established complication rates were more appropriate and had the Claimant been made aware of the true risks of surgery she would have declined surgery.”
Q1 – Is it appropriate to use personal audited and verified complication rates for the purposes of consent when that surgeon will be operating?
Y/N
2- A patient has bilateral carpal tunnel syndrome and is due to have a carpal tunnel decompression to their right hand. They are appropriately consented and all the risks and benefits of the procedure are explained. The procedure is successful. The patient returns for their left hand surgery. The operating surgeon states “the procedure will be exactly the same this time as last time. If you are happy to proceed then please sign the same consent form you signed previously.”
Q2 – Is this adequate consent?
Y/N
3- Data suggests that trainees undertaking procedure x have a higher complication rate than consultants undertaking the same procedure. A patient attends for procedure x and a trainee will be undertaking it.
Q3a – Is the trainee operating a material risk of procedure x?
Y/N
Q3b – Should this material risk be disclosed and discussed with the patient?
Y/N
4- A patient attends for an endoscopy. They state categorically that they do not wish to know about any of the potential complications and that they trust the hospital and the doctor doing it.
Q4 – Should we respect the patients wishes?
Y/N
5- A patient attends for a cataract operation. They are consented for the risk of some visual loss (1:100), risk of losing the eye (1:10000), infection (1 in 800), blindness (1:1000). They develop a complication following surgery called cystoid macular oedema. This occurs due to inflammation causing swelling of the retina at the back of the eye. It usually resolves with medical therapy (eye drops and potentially intraocular or periocular injections). In the patient’s case the vision does not resolve and they were left with vision significantly worse than pre-operatively. The patient litigates.
Claimants argument: “The Claimant was not informed appropriately of the risks of cystoid macular oedema (swelling at the back of the eye). It was not mentioned on the consent form and it was not discussed with the Claimant at any time. Had the Claimant been made aware of the risk of swelling and the fact that it sometimes does not resolve she would have not proceeded with surgery.”
Defendants argument: “We accept that the specific complication of cystoid macular oedema was not documented and not discussed with the Claimant however the risk of visual loss was clearly discussed and explained to the Claimant. The exact mechanism of the visual loss is not relevant and the duty of care of the clinician is to ensure that a patient knows the material risks of potential adverse outcomes and not exactly the mechanism of those outcomes.”
Cystoid macular oedema occurs in between 0.1–2.35% of cataract cases.
Q5a – Is cystoid macular oedema a material risk of cataract surgery?
Y/N
Q5b – Should the Claimant have been made aware of the risk of cystoid macular oedema?
Y/N
Q5c – Does the Claimant have a valid case that the consent was inadequate?
Y/N
The anonymised responses will be collated and presented in the next edition with a discussion of the findings.
I am very grateful in advance for your time and assistance in answering the questions.
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